Journal of the American Academy of Child & Adolescent Psychiatry
New researchInternet-Based, Randomized, Controlled Trial of Omega-3 Fatty Acids for Hyperactivity in Autism
Section snippets
Participants
The study protocol was approved by the Committees on Human Research at the University of California, San Francisco and at Johns Hopkins University. The trial was registered before enrolling patients at clinicaltrials.gov (NCT 01694667) and took place between September 18, 2012 and December 31, 2012.
Recruitment was limited to children between the ages of 5 and 8 with some verbal ability (as defined by question 1 of the Social Communication Questionnaire or SCQ) who were enrolled in the
Results
During the 6-week recruitment period, e-mail recruitment notices were sent to 863 IAN members meeting initial age and ASD diagnostic criteria, and 118 families expressed interest and completed the online screening form. A total of 57 children from 28 states were deemed eligible and randomly assigned to study treatment. After the study was completed, it was discovered that a programming error had resulted in 3 participants being included who were not eligible: 1 patient in the omega-3 group had
Discussion
This study demonstrates the feasibility of conducting an IB-RCT in children with ASD. In just 6 weeks, 57 children from 28 states completed all eligibility criteria screenings and were enrolled. The response rate (118 responses to 863 e-mail invitations, or 13.7%) is a statistic that is most often reported for survey responses and not for acceptance to invitations for clinical trials. Although the response rate in this study is relatively low compared to those in published surveys, it is
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This article was reviewed under and accepted by deputy editor John T. Walkup, MD.
This work was supported by a grant from the Simons Foundation (SFARI 206484, S.B.) and by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through UCSF-CTSI Grant Number UL1 RR024131.
Mr. Kalb served as the statistical expert for this research.
Disclosure: Drs. Bent, Hendren, K. Law, and P. Law, and Ms. Zandi, Ms. Choi, Ms. Widjaja, Mr. Kalb, and Mr. Nestle report no biomedical financial interests or potential conflicts of interest.